U.S. patent number 6,656,173 [Application Number 09/845,774] was granted by the patent office on 2003-12-02 for method and device for enhancing vessel occlusion.
This patent grant is currently assigned to Radio Therapeutics Corporation. Invention is credited to Thomas Palermo.
United States Patent |
6,656,173 |
Palermo |
December 2, 2003 |
Method and device for enhancing vessel occlusion
Abstract
Body lumens such as blood vessels are selectively occluded by
applying radiofrequency voltage to a vaso-occlusive coil (100) at
the target site (TS) and generating a thermal reaction to induce
fibrogenic occlusion of the blood vessel (BV) around the
vaso-occlusive coil. The radiofrequency current is usually
sufficient to induce thermal damage to the luminal wall and to
coagulate the surrounding blood, thereby initiating clotting and
subsequent fibrosis to permanently occlude the lumen. The invention
also includes a method for endoluminally deploying the
vaso-occlusive coil and preventing migration of the coil from of
the target site.
Inventors: |
Palermo; Thomas (San Jose,
CA) |
Assignee: |
Radio Therapeutics Corporation
(Mountain View, CA)
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Family
ID: |
24425118 |
Appl.
No.: |
09/845,774 |
Filed: |
April 30, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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605765 |
Feb 22, 1996 |
6270495 |
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Current U.S.
Class: |
606/32;
606/51 |
Current CPC
Class: |
A61B
17/12022 (20130101); A61B 17/1214 (20130101); A61B
18/1492 (20130101); A61B 18/1442 (20130101); A61B
2018/00214 (20130101); A61B 2018/1253 (20130101) |
Current International
Class: |
A61B
17/12 (20060101); A61B 18/14 (20060101); A61B
018/04 () |
Field of
Search: |
;606/41-52,157,158 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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25 40 968 |
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Mar 1977 |
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DE |
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26 46 228 |
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Apr 1978 |
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DE |
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41 39 029 |
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Jun 1993 |
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DE |
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2-121675 |
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May 1990 |
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JP |
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WO 93/01758 |
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Feb 1993 |
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WO |
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WO 93/06884 |
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Apr 1993 |
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WO |
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WO 94/06503 |
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Mar 1994 |
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WO |
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WO 94/09705 |
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May 1994 |
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WO |
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WO 94/10936 |
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May 1994 |
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WO |
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WO 94/11051 |
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May 1994 |
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WO |
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WO 95/02366 |
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Jan 1995 |
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WO |
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Other References
Becker et al., "Catherter for Endoluminal Bipolar
Eletrocoagulation", 1989, Radiology, vol. 170, pp. 561-562. .
Becker et al., "Long-Term Occlusion of the Porcine Custic Duct by
Means of Endoluminal Radio-Frequency Electrocoagulation", 1988,
Radiology, vol. 167, pp. 63-68. .
Brunelle et al., "Endovascular Electrocoagulation with a Bipolar
Electrode and Alternating Current: A Follow-up Study in Dogs",
1983, Radiology, vol. 148, pp. 413-415. .
Cragg et al., "Endovascular Diathermic Vessel Occlusion", 1982,
Radiology, vol. 144, pp. 303-308. .
Grant Application, Department of Health and Human Services, Public
Health Service, From the Regents of University of California, 405
Hilgard Avenue, Los Angeles, CA. 58 pages total. .
Tanigawa, N. et al., "Interaarterial Occlusion By Radiofrequency",
1994, Acta Radiological, ISSN 0248-1851, pp. 626-628..
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Primary Examiner: Dvorak; Linda C. M.
Assistant Examiner: Vrettakos; Peter J
Attorney, Agent or Firm: Bingham McCutchen LLP
Parent Case Text
This application is a continuation of U.S. patent application Ser.
No. 08/605,765, filed Feb. 22, 1996, now issued as U.S. Pat. No.
6,270,495, the entire disclosure of which is expressly incorporated
by reference herein.
Claims
What is claimed is:
1. A lumen occlusion system, comprising: a source of high frequency
electrical energy; an introducer having a shaft with proximal and
distal ends and an axial lumen therebetween; a positioner disposed
within the axial lumen and having a shaft and a distal engaging
element for contacting a vaso-occlusive element at a target site
within a body lumen, the distal engaging element comprising a first
electrode coupled to the source of high frequency electrical
energy; and a second electrode coupled to the source of high
frequency electrical energy wherein the distal engaging element has
an opened and closed configuration, and the positioner is slidable
relative to the introducer to close the distal engaging element
when the distal engaging element is unconfined outside the axial
lumen of the introducer.
2. The system of claim 1 wherein the distal engaging element
comprises means for advancing the vaso-occlusive element through
the axial lumen of the introducer to a target site in a body
lumen.
3. The system of claim 1 wherein the distal engaging element
comprises a holding member for releasably holding a portion of a
vaso-occlusive element.
4. The system of claim 1 wherein the holding member is configured
to releasably hold the vaso-occlusive element beyond the distal end
of the introducer.
5. The system of claim 1 wherein the second electrode comprises an
external dispersive electrode adapted for engaging an external
portion of the patient's body.
6. The system of claim 1 wherein the second electrode is a return
electrode coupled to the introducer shaft, the return electrode
being spaced from and electrically insulated from the first
electrode.
7. The system of claim 1 wherein the first and second electrodes
are located on the distal engaging element and the positioner shaft
for initiating current therebetween.
8. The system of claim 1 wherein the introducer is a flexible shaft
having dimensions suitable for introduction to a patient's
vasculature.
9. The system of claim wherein the source of radiofrequency energy
is configured to apply radiofrequency energy at a frequency of at
least 200 kHz to the vaso-occlusive element.
10. A lumen occlusion system, comprising: a source of high
frequency electrical energy; an introducer having a shaft with
proximal and distal ends and an axial lumen therebetween; a
positioner disposed within the axial lumen and having a shaft and a
distal engaging element for contacting a vaso-occlusive element at
a target site within a body lumen, the distal engaging element
comprising a first electrode coupled to the source of high
frequency electrical energy; and a second electrode coupled to the
source of high frequency electrical energy; wherein the distal
engaging element comprises a plurality of opposed members movable
between open and closed positions, at least one of the opposed
members comprising the first electrode.
11. The system of claim 10 wherein the positioner further includes
a proximal actuator for opening and closing the opposed
members.
12. The system of claim 10 wherein the opposed members are biased
towards each other.
13. A lumen occlusion device for use with a source of high
frequency electrical energy comprising: an introducer having a
shaft with proximal and distal ends and an axial lumen
therebetween; a positioner slidably disposed within the axial lumen
and having a distal engaging element for releasably engaging an
electrically conductive vaso-occlusive element at a target site
within a body lumen, the distal engaging element comprising an
electrode; and an electrical conductor for coupling the electrode
to the source of high frequency electrical energy wherein the
distal engaging element has an opened and closed configuration, and
the positioner is slidable relative to the introducer to close the
distal engaging element when the distal engaging element is
unconfined outside the axial lumen of the introducer.
14. The device of claim 13 wherein the distal engaging element
comprises means for releasably holding the vaso-occlusive element
in contact with the electrode beyond the distal end of the
introducer.
15. The device of claim 13 wherein the distal engaging element
comprises a distal surface sized to engage the vaso-occlusive
element and to push said element through the axial lumen of the
introducer, the vaso-occlusive element being released from the
distal surface of the engaging element when the vaso-occlusive
element is pushed beyond the distal end of the introducer
shaft.
16. The device of claim 13 wherein the distal engaging element
comprises a plurality of opposed elements movable between open and
closed positions, at least one of the opposed elements comprising
the first electrode.
17. The system of claim 16 wherein the positioner further comprises
a proximal actuator for opening and closing the opposed
elements.
18. The system of claim 16 wherein the opposed elements are biased
towards each other.
19. The device of claim 13 wherein the introducer is a flexible
catheter.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to methods and devices for
the selective occlusion of body lumens. More particularly, the
present invention relates to methods and devices for applying high
frequency electrical energy to vaso-occlusion elements within the
body lumen to enhance fibrogenic occlusion of the body lumen.
The selective occlusion of blood vessels in a patient is a part of
many modem therapeutic treatments, including the control of
internal bleeding, the occlusion of blood supply to tumors, the
isolation of diseased body organs prior to removal, the relief of
blood pressure in a region of aneurism, and the like. While such
procedures rely generally on the blockage of arteries, the
selective occlusion of veins is also useful in procedures such as
veiniotomy.
The selective occlusion of blood vessels can be achieved by a
variety of specific techniques. One such technique involves
mechanically clamping or occluding the target site within the blood
vessel. For example, in open surgical and endoscopic procedures,
the body vessel can be externally clamped and radiofrequency energy
applied. While the external procedures can be very effective, it
requires external access to the lumen and is unsuitable for
endoluminal techniques.
Mechanical endoluminal techniques for selective vessel occlusion
are also in use. Such techniques include the use of detachable
balloons, embolic and vaso-occlusion coils, and the like to
physically block the vessel lumen. Detachable balloons are
typically advanced to the vessel site at the end of a catheter and
inflated with a suitable fluid, such as saline, x-ray contrast or a
polymerizable resin, and released from the end of the catheter.
These detachable balloons, however, are difficult to deliver and
may not be suitable for permanent implantation unless they are used
with the polymerizable resin. In addition, the catheter or the
balloon can rupture or release prematurely during filling, leaking
monomer resin into the vasculature.
Embolic or vaso-occlusion coils are typically introduced through a
catheter in a stretched linear form, and assume a relaxed, helical
shape when released into a vessel. One of the limitations of these
coils is that recanalization of the occlusion site can occur when
the initial blood clot is broken down by the body's natural
anticoagulant mechanism (i.e., resorption of the clot). In
addition, once the embolic coils are released by the introducer
catheter, they are no longer under control and they frequently
migrate from the point of initial implantation.
To completely arrest the flow of blood in a vessel and to inhibit
recanalization, current methods of coil embolization typically
require the use of several embolic coils at the target site in the
blood vessel. In this "nesting technique", the embolic coils are
deposited within a vessel to create a mechanical "plug". It has
been found, however, that the use of several coils does not always
prevent recanalization of the blood vessel, particularly in larger,
high flow vessels. Moreover, it often takes a relatively long time
for the blood vessel to completely occlude. Therefore, the embolic
coils may often migrate into a non-target site prior to vessel
occlusion, particularly in larger or high flow vessels. Multiple
coils are also more expensive than a single coil and they require
more time to position within the vessel, thereby further increasing
the cost of the procedure and prolonging the patient's exposure to
the fluoroscope.
Of particular interest to the present invention, the use of
monopolar and bipolar radiofrequency devices has been proposed for
the occlusion of body vessels from a surrounding lumen or body
cavity. For example, U.S. Pat. No. 5,403,311 describes control of
vessels bleeding into a body lumen using electrosurgical electrodes
which puncture the vessel from within a larger lumen enclosing that
vessel. Catheters for radiofrequency injury and occlusion of the
cystic duct are described in Becker et al. (1989) Radiology
170:561-562 and (1988) Radiology 167:63-68 and Tanigawa et al.
(1994) Acta Radiologica 35:626-628. Methods and catheters for
electrosurgical endovascular occlusion are described in Brunelle et
al. (1980) Radiology 137:239-240; Cragg et al. (1982) Radiology
144:303-308; and Brunelle et al. (1983) Radiology 148:413-415. Such
techniques, however, have not generally been useful in large or
high flow blood vessels.
For these reasons, it would be desirable to provide improved
methods and devices for endoluminal occlusion of body lumens, and
particularly of blood vessels, for use in the procedures described
above. Such methods and devices should provide effective occlusion
of large or relatively high flow body lumens as well as small body
lumens. Preferably, the methods and devices will permit the
physician to re-access the occlusion site, to correct
recanalization and/or to enhance the occlusion of this site to
prevent subsequent recanalization of the body lumen.
2. Description of the Background Art
Methods and devices for implanting vaso-occlusive elements, such as
coils, in blood vessels and other lumen are described in U.S. Pat.
Nos. 5,354,295; 5,350,397; 5,312,415; 5,261,916; 5,250,071;
5,234,437; 5,226,911; 5,217,484; 5,122,136; 5,108,407; `4,994,069;
and 3,868,956; and published PCT applications WO 94/11051; WO
94/10936; WO 94/09705; WO 94/06503; and WO 93/06884. Some of the
devices described in the above listed patents and published
applications suggest passing direct current through the element to
enhance blood clotting.
Electrosurgical probes for electrosurgical, electrocautery, and
other procedures are described in U.S. Pat. Nos. 5,405,322;
5,385,544; 5,366,490; 5,364,393; 5,281,216; 5,236,410; 4,685,459;
4,655,216; 4,582,057; 4,492,231; 4,209,018; 4,041,952; 4,011,872;
4,005,714; 3,100,489; 2,022,065; 1,995,526; 1,943,543; 1,908,583;
and 1,814,791; and published Japanese application 2-121675;
published German applications DE 4139029; DT 2646228; and DT
2540968; and published PCT applications WO 95/02366 and WO
93/01758.
A method and system employing RF energy for the direct occlusion of
blood vessels and other body lumens are described in co-pending
application Ser. No. 08/488,444 filed on Jun. 7, 1995 (attorney
docket No. 16807-3), the full disclosure of which is incorporated
herein by reference. See also the patent and publications described
in the Field of the Invention above.
SUMMARY OF THE INVENTION
Methods and apparatus are provided for deploying vaso-occlusive
elements into body lumens, such as blood vessels, to occlude a
target site within the lumen and for enhancing the occlusion of
body lumens that already have vaso-occlusive elements deployed
therein. The technique involves applying high frequency electrical
energy to an electrically conductive, vaso-occlusive element and
generating a thermal reaction at the target site to damage the
luminal wall and induce fibrogenic occlusion of the blood vessel
around the vaso-occlusive element. The vaso-occlusive element,
which is typically an electrically conductive wire coil, helps
reduce blood flow within the vessel and provides a larger surface
for energy transfer between the electrical energy source and the
tissue wall and surrounding blood. The high frequency electrical
energy, typically radiofrequency current, is usually sufficient to
induce local heating of the luminal wall and also to enhance
coagulation of the surrounding blood, thereby initiating clotting.
The thermally injured wall then contributes to subsequent fibrosis,
thus permanently occluding the lumen.
The vaso-occlusive coil typically has a relatively low electrical
resistance so that the high frequency electrical energy flows
directly through the vaso-occlusive coil to the luminal wall (i.e.,
without substantially heating the coil). The electrical energy
heats the luminal wall, thereby causing damage and subsequent
fibrogenic occlusion of the target site. Alternatively, the
vaso-occlusive coil may comprise sufficient electrical resistance
such that a portion of the high frequency electrical energy is
transferred directly to the coil (rather than the luminal wall) to
heat the coil and enhance occlusion around the coil. In this case,
the vaso-occlusive coil will preferably have an electrical
resistance slightly less than the tissue wall to ensure that the
electrical energy flows through at least a substantial portion of
the coil.
In one aspect, the method comprises contacting a vaso-occlusive
coil that is already deployed at a target site within a body lumen
with at least one electrode and applying the high frequency
electrical energy to the coil in a monopolar or bipolar fashion.
Preferably, the energy is applied in a monopolar mode by contacting
the patient's body with a second, dispersive or return, electrode
and then delivering a high frequency current to the first or active
electrode, through at least a portion of the vaso-occlusive coil,
the surrounding tissue, and finally to the second electrode. For
bipolar operation, a separate second electrode may be provided on
the catheter, typically spaced proximally from the first electrode
so that it will be located within the body lumen. The second
electrode will usually be spaced a distance of about 2 mm to 10 cm
from the active electrode.
The first electrode will usually be disposed on the distal end of
an intravascular catheter. The catheter can be percutaneously
introduced via well-known procedures and advanced to the target
site in a body lumen in a known manner, typically over a guide
wire. The first electrode can be engaged against the vaso-occlusive
coil in a variety of ways. For example, the electrode (and
optionally a pair of electrodes for bipolar operation) can simply
be disposed at a distal location on the catheter which will contact
the vaso-occlusive coil when the catheter is advanced through the
body lumen to the target site.
Alternatively, the electrode may be provided by a separate member,
such as an insulated conventional or specialized guide wire, or a
positioner device, which may be insulated by the catheter body. In
use, the guideline positioner is extended distal to the catheter
body, placed against the vaso-occlusive coil, and the
radiofrequency current is applied thereto. In the latter case, a
distal portion of the positioner may comprise the active electrode,
while the return electrode is located on the catheter or placed
externally on the patient.
In other aspects, the method may comprise deploying the
vaso-occlusive coil at the target site within the body lumen,
adjusting the position of an already deployed vaso-occlusive coil
within the target site, or repositioning the coil to another
location in the vasculature. For initial deployment, the
vaso-occlusive coil will be releasably engaged by the positioner
and optionally advanced through the axial lumen of the catheter for
deployment. For repositioning, the coil may be captured by the
positioner and partially or fully retracted into the axial lumen
for adjusting coil placement or repositioning the coil to another
location. Typically, the coil will be repositioned when previous
attempts to occlude a target site have not completely succeeded and
the coil is not fixed at the site. A particular advantage of the
present invention is that the coil can be held in place within the
body lumen by the positioner until the high frequency voltage or
current has been applied thereto. Once the voltage has generated a
sufficient thermal reaction to induce spasm and localized
edema/narrowing of the vessel (and subsequent fibrogenic occlusion
of the lumen) around the coil, the coil will be released from the
positioner and the positioner removed from the vasculature. In this
manner, the fibrogenic occlusion of the blood vessel will slowly
and permanently lock the coil in position at the occlusion site,
while the coil is temporarily held in place by the spasm or
narrowing of the vessel. This prevents or at least inhibits
migration of the coil downstream through the body lumen after it
has been released by the positioner.
Devices according to the present invention will generally comprise
a shaft having proximal and distal ends and an axial lumen
therebetween. For vascular applications, the shaft will typically
be a non-conductive, tubular catheter body capable of being
introduced to the vascular system over a guide wire in a
conventional manner. A positioner is slidably disposed within an
axial lumen of the shaft and includes a first electrode at the
distal end for contacting the vaso-occlusive coil. The positioner
may be a guide wire that is also used for advancing the shaft
through the body lumen or a separate device inserted into the
catheter body after it has been advanced to the target site. The
first electrode is coupled to a source of high or radiofrequency
electrical energy by the positioner itself, an electrical conductor
extending through the positioner, or through the catheter body.
The positioner preferably comprises a conductive shaft having an
outer insulating sheath extending to a distal portion of the shaft.
The distal portion includes an engaging element for releasably
engaging the vaso-occlusive coil to either deploy the coil at the
target site or to reposition a deployed coil to another location in
the patient's vasculature. In one embodiment, the engaging element
comprises a pair of opposed elements which can be selectively
opened and closed to engage and release a proximal portion of the
coil. Usually, the opposed elements will be openable jaws that are
actuated manually with an actuator located on a handle at the
proximal end of the positioner. In another embodiment, the distal
engaging element comprises a plurality of resilient hooks that are
biased away from each other and held together by the catheter body.
In yet another embodiment, the distal engaging element comprises a
distal pusher element adapted to contact the coil and push it
through the catheter body to the target site.
The system of the present invention will also include a second
electrode operatively coupled to the high frequency energy source.
The second electrode can be either a second bipolar electrode
disposed on the positioner (usually spaced proximally from the
first electrode), the catheter. or introducing sheath, or a
dispersive or return electrode attachable directly to the patient's
skin (where the first or active electrode will function in a
monopolar manner). The electrodes are thus utilized to apply
monopolar or bipolar high frequency energy to the vaso-occlusive
coil within the vessel lumen. For example, a separate guide wire
could be provided as either a monopolar or one bipolar
electrode.
Frequently, the first electrode(s) will be associated with the
distal engaging elements. For example, the opposing jaws or the
resilient hooks can also define the treatment electrodes on the
positioner. In the bipolar mode, most likely, a separate, second
radiofrequency electrode can be provided on the catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a lumen occlusion system constructed
in accordance with the principles of the present invention;
FIG. 2 is an enlarged perspective view of a distal end of a
positioner device of the lumen occlusion system of FIG. 1,
illustrating a pair of opposed elements shown in their open
configuration;
FIGS. 3A-3D illustrate the use of the system of FIG. 1 and a method
for enhancing occlusion of a blood vessel according to the
principles of the present invention;
FIG. 4 is a sectional view of the distal portion of a second
embodiment of a lumen occlusion device, illustrating a method of
deploying or repositioning a vaso-occlusive coil in a body
lumen;
FIG. 5 is a detailed, cross-sectional view of the lumen occlusion
device of FIG. 4, illustrating a plurality of coil-engaging
elements releasably holding the vaso-occlusive coil;
FIG. 6 is a partial sectional view of a third embodiment of a lumen
occlusion device constructed in accordance with the principles of
the present invention; and
FIG. 7 is a partial sectional view of a portion of a lumen
occlusion device according to another embodiment of the present
invention.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
The methods and devices of the present invention will be useful for
selectively occluding virtually any body lumen that can be occluded
with a vaso-occlusive element(s) followed by the application of
energy. While the present invention will find its greatest use in
the selective occlusive of blood vessels, including both arteries,
veins, fistulas and aneurysms, it will also find use with other
body lumens, such as the fallopian tubes, bile ducts, and the like.
The present invention will be particularly useful for occluding
relative large, high flow arteries, veins and vascular
malformations, because the present invention presents a method of
releasably holding a vaso-occlusive element(s) until the target
site of the fluid vessel is partially or completely occluded. In
high flow vessels, this effectively prevents the vaso-occlusive
element(s) from becoming dislodged and migrating downstream of the
target site.
In the case of blood vessel occlusion, the high frequency
electrical energy will coagulate surrounding fluids, such as blood,
and thermally injure the intima of the body luminal wall in the
occlusion region, thus initiating a process of thrombosis and
fibrosis which will result in relatively complete vessel occlusion.
The high frequency electrical energy passes through the
vaso-occlusive element, which usually takes the form of an
electrically conductive coil, into the body luminal wall. The
electrical energy heats the luminal wall, thereby enhancing the
thrombogenic and fibrogenic occlusion of the coil at the target
site. The vaso-occlusive coil typically has a relatively low
electrical resistance so that the high frequency electrical energy
flows directly through the coil to the luminal wall and surrounding
fluid (in fluid carrying vessels) without substantially heating the
coil. The electrical energy heats the body luminal wall, creating a
thermal effect and thereby causing damage and subsequent fibrogenic
occlusion of the target site. The temperature of the luminal wall
will be typically be raised to about 45.degree. C. to 95.degree.
C., preferably about 55.degree. C. to 85.degree. C.
Alternatively, the vaso-occlusive coil may comprise a material
having some electrical resistance so that a portion of the high
frequency electrical energy heats the vaso-occlusive coil. In this
case, the coil will preferably have an electrical resistance less
than the tissue wall to ensure that the electrical energy flows
through at least a substantial portion of the coil.
Preferably, the energy source will provide radiofrequency
electrical energy, such as that supplied by conventional
electrosurgical power supplies, such as those available from
commercial vendors, including Valleylab.RTM., Aspen.RTM.,
Bovie.RTM., and Birtcher.RTM.. The power supply will usually
provide energy at frequencies from 200 kHz to 12 MHz, preferably
from 250 kHz to 500 kHz and may employ a conventional sinusoidal or
non-sinusoidal wave form. The current provided will usually be in
the range from about 25 mA to 1 A, preferably from about 50 mA to
250 mA from about 5 seconds to 4 minutes, usually from 10 seconds
to 1 minute. The actual amplitude and duration of the current will
depend primarily on vessel size, i.e. larger vessels will usually
require higher currents and longer durations.
As discussed in more detail in connection with the specific
embodiments below, the RF current may be applied in a monopolar or
a bipolar fashion in or near the occlusion region. By "monopolar"
it is meant that current flow will pass between (1) one or more
"active" electrodes on the introducing catheter or the positioner
which have surface areas and configurations which transfer the
energy to the vaso-occlusive coil in order generate a thermal
reaction in the region of the target site; and (2) a "dispersive"
or return electrode which is located remotely from the active
electrode(s) and which has a sufficiently larger area so that the
current density is low and non-injurious to surrounding tissue. In
some cases, the dispersive electrode may be on the same probe as
the active electrode, and in other cases, the dispersive electrode
may be attached externally to the patient, e.g., using a contact
pad placed on the patient's flank.
Bipolar devices according to the present invention will generally
employ a pair of electrodes in relatively close proximity each
having an area and geometry selected to have a desired physiologic
effect on adjacent tissue. In the case of bipolar devices, one or
more electrodes will be connected to one pole of the radiofrequency
power supply and will be placed in contact with the vaso-occlusive
coil. The other electrode will be directly or indirectly in contact
with the body luminal wall. Thus, the current flow in the occlusion
region will be concentrated through the vaso-occlusive coil, then
through the luminal wall or through the fluid located between
electrode pair(s), rather than from one or more electrodes to a
remote, dispersive electrode (which is the case in monopolar
operation).
Devices according to the present invention will comprise an
introducing catheter, typically including a shaft having proximal
and distal ends and an axial lumen therebetween. For vascular
applications, the shaft may be in the form of a conventional
catheter body, typically having a length in the range from 40 cm to
200 cm, usually from 75 cm to 120 cm. The catheter body will
usually include means for introducing the body over a movable guide
wire, typically having a guide wire lumen running through at least
a distal portion of the catheter body. Thus, the catheter body can
have either conventional "over-the-wire" design where a movable
guide wire is received through the entire length of the catheter
body or may have a "rapid exchange" or "monorail" design where the
guide wire is received through a lumen which extends only over a
distal length of the body, typically from 5 cm to 25 cm. The
catheter body will have an outside diameter consistent with its
intended use, typically being from 1 mm to 5 mm, usually from 2 mm
to 4 mm.
The catheter body may be formed from a variety of conventional
catheter materials, including natural and synthetic polymers, such
as polyvinyl chloride, polyurethanes, polyesters, polyethylenes,
polytetrafluoroethylenes (PTFE's), nylons, and the like. The
catheter bodies may optionally be reinforced to enhance their
strength, torqueability, and the like. Exemplary reinforcement
layers include metal fiber braids, polymeric fiber braids, metal or
fiber helical windings, and the like. Optionally, a portion of the
catheter body could be formed from a metal rod or hypo tube,
particularly when the catheter body is a rapid exchange or monorail
design.
The catheter will also include at least one electrode for
initiating radiofrequency current flow, as described above. The
electrode may be disposed on the catheter shaft, may be part of a
separate positioner (described below), and/or may be associated
with the guide wire used to introduce the shaft to the body lumen,
usually a blood vessel. Configuration of the electrode element will
vary depending on whether it is intended to actively contact the
vaso-occlusive coil or to function as a return or dispersive
electrode.
The dispersive electrode will typically have a substantially larger
surface area, on the order of at least 2 to 3 times larger, than
the active electrode. Active electrodes (the electrode and the
occlusive coil) will typically have relatively small total surface
areas, typically being below about 20 mm.sup.2, usually being below
about 10 mm.sup.2. Dispersive electrodes will typically have a
somewhat larger area, typically being greater than 50 mm.sup.2 for
probe-mounted dispersive electrodes and greater than 120 cm.sup.2
for external dispersive pads.
The positioner will generally comprise a shaft that extends through
the catheter body and includes a distal engaging element for
releasably engaging a vaso-occlusive coil. The distal engaging
element will also comprise the active electrode(s) (or one of a
pair of electrodes in the bipolar mode). The engaging element will
preferably comprise a holding or grasping mechanism that holds a
proximal portion of the coil for deploying and/or repositioning the
coil within a blood vessel. In this embodiment, the engaging
element will be capable of holding onto the coil beyond the distal
end of the catheter body and/or grasping an already deployed coil
for establishing positive electrical contact between the engaging
element and the coil, repositioning the coil or withdrawing the
coil from the body lumen. Alternatively, the engaging element may
comprise a mechanism for contacting the coil and pushing the coil
through the catheter body. In this embodiment, the coil will
generally disengage from the engaging element when its proximal end
moves past the distal end of the catheter body. Electrical current
may be re-established by subsequently advancing the positioner to
contact the coil. Specific examples of each of these approaches are
described in more detail in connection with the figures below.
The present invention will generally be useful with virtually any
type of vasoocclusive device or coil that may be endoluminally
advanced to a target site of a body lumen to block fluid passage
therethrough. The vaso-occlusive device will typically be formed
from an elongate element, such as a wire, which is extendable from
a relaxed, convoluted condition, to an extended, linear condition
in which the wire can be advanced through the catheter. The
vaso-occlusive coil(s) will have a relatively large surface area
compared to the electrode to facilitate transfer of the electrical
energy to the tissue wall and surrounding blood. This surface area
will usually depend on the size of the coil, which is typically
chosen based on the size of the blood vessel. Larger vessels will
typically require a higher rate of energy transfer due to a larger
surface area.
The vaso-occlusive wire generally takes the form of a coil, and may
be formed by wrappings or windings of a fine wire comprised of
platinum, stainless steel, tungsten, gold or the like. The wire may
be covered with a fibrous material, such as polyester, to induce
thrombus in blood. The wire may be pre-formed so that it adopts a
convoluted configuration in a relaxed condition. Alternatively, the
vaso-occlusive device may be formed from a flexible pre-shaped
polymer tube or rod that is doped with electrically conducting
material so that the rod is more electrically conductive than the
tissue of the body lumen. The convoluted shape of the tube or rod
may be achieved by a combination of a helical winding and/or
irregularities which are imparted during heat treatment, or by
shaping the device as it is extruded, before cooling, or by
injection molding.
Referring now to FIGS. 1-3, a lumen occlusion system 2 according to
the present invention comprises a shaft in the form of a flexible
catheter body 4 having a proximal end 6 and a distal end 8. A
positioner 10 includes a flexible shaft 12 sized to extend through
catheter body 4 and having a proximal end 13 attached to a handle
14. A pair of opposing elements or jaws 16, 17 are attached to a
distal end 15 of flexible shaft 12 for movement between open and
closed positions. Once catheter body 4 has been positioned within a
blood vessel of the patient (discussed below), jaws 16, 17 may be
introduced through proximal end 6 of catheter body 4 and advanced
through distal end 8, as shown in FIG. 1.
Handle 14 includes an actuator mechanism for opening and closing
jaws 16, 17. Preferably, the actuator mechanism comprises an inner
rod 20 slidably disposed within shaft 12 and extending through an
inner lumen 22 within handle 14. Rod 20 is coupled to a trigger 24
having a lever arm 26 extending through a slot 28 in handle 14.
Distal movement of lever arm 26 through slot 28 moves rod 20 in the
distal direction, causing jaws 16, 17 to open (see FIG. 2). A
spring 30, positioned between a bushing 32 within lumen 22 and
trigger 24, biases lever arm 26 proximally so that jaws 16, 17 are
biased into the closed position (FIG. 1).
FIG. 2 illustrates a preferred embodiment of the distal end 15 of
positioner 10.
As shown, jaws 16, 17 are pivotally coupled to each other by a
pivot pin 60 extending through jaw 17. Jaw 17 has a proximal end
portion 62 pivotally coupled to a linkage 64 which is, in turn,
pivotally coupled to the distal end 66 of rod 20. Proximal movement
of rod 20 withdraws linkage 64 into shaft 12, thereby pivoting
proximal end portion 62 of jaw 17 toward shaft 12. In this manner,
distal end portion 70 of jaw 17 is pivoted downward towards jaw 16
into the closed position (FIG. 1). Jaw 16 preferably has a recess
72 sized to receive jaw 17 to minimize the profile of positioner 10
in the closed position. Similarly, distal movement of rod 20 causes
jaws 16, 17 to open (FIG. 2).
In this embodiment, jaws 16, 17 also serve as a common active
electrode for providing radiofrequency current flow in a monopolar
procedure. Referring again to FIG. 1, occlusion system 2 further
comprises a suitable RF power supply 40 connected to handle 14 via
a connection plug 42. Jaws 16, 17 are preferably coupled to
connection plug 42 through inner rod 20 and a lead wire 44 within
handle 14. Inner rod 20 may comprise an electrically conducting
material or a lead wire (not shown) may extend through an inner
lumen within rod 20. Positioner shaft 12 will be fabricated from an
insulating material to insulate rod 20 from the patient. The
occlusion system 20 further includes a dispersive or return
electrode, which is an external dispersive plate 50 coupled to RF
power supply 40 and adapted for mounting on the patient's skin. Of
course, the dispersive electrode 50 could be located elsewhere in
different form (e.g., a sleeve) on the catheter body 4.
FIGS. 3A-3C illustrate use of the lumen occlusion system 2 to
enhance occlusion of a target site TS within a blood vessel BV
having one or more vaso-occlusive coils 100 already deployed at the
target site TS. The physician will typically monitor the blood
vessel with a fluoroscope to determine whether the vessel is
completely occluded after coil 100 has been deployed (or to
determine if recanalization has subsequently taken place). If the
target site is not completely occluded, lumen occlusion system 2
will be used to apply radiofrequency energy to the coils at the
target site to cause thermal damage to the luminal wall (this will
induce a fibrogenic reaction). Of course, system 2 can also be
utilized to deploy the initial coil 100 (or additions to the coil)
at target site TS, as described in more detail in later
embodiments.
Referring to FIG. 3A, the distal end 8 of catheter body 4 is
introduced transluminally to a target site TS within a blood vessel
BV or other body lumen. Typically, a guide wire (not shown) will
first be introduced to the target site TS in a conventional manner.
Note that positioner 10 may also be used as the guide wire, if
desired, or positioner 10 may be used without the catheter if no
additional coils are necessary. Once the guide wire is in position,
the catheter body 4 will be introduced over the guide wire in a
conventional "over-the-wire" manner until the distal end 8 of the
body 14 is positioned slightly proximal of the vaso-occlusive coil
100, as shown in FIG. 3A.
After reaching the target site TS, positioner shaft 12 is advanced
through catheter body 4 until jaws 16, 17 extend beyond distal end
8. Positioner shaft 12 will include an outer insulating sheath 102
proximal to the grasping end to protect the blood vessel wall from
electrical energy delivered therethrough (discussed below). Jaws
16, 17 are opened by moving lever arm 26 (FIG. 1) in the distal
direction, as described above. As shown in FIG. 3B, positioner
shaft 12 will then be advanced distally until jaws 16, 17 contact a
proximal portion of coil 100. As shown in FIG. 3C, jaws 16, 17 are
preferably closed over a portion of coil 100 to establish
electrical contact between the active electrodes (jaws 16, 17) and
the coil and to ensure that this electrical contact remains intact
during application of energy to the coil. A radiofrequency power
supply 40 (FIG. 1) applies a radiofrequency voltage to jaws 16, 17
to initiate a radiofrequency current flow between the contiguous
coil 100 and the return electrode 50. The radiofrequency power
supply 40 may be optionally modified to provide an optimum
impedance match. The radiofrequency current flows through coil 100,
and the surrounding blood and the wall of blood vessel BV. The
current thermally damages the blood vessel wall, causing localized
swelling around the coil, as shown in FIG. 3C.
After maintaining the radiofrequency current flow for a desired
time and at a desired current level, jaws 16, 17 will be opened to
release coil 100. The positioner 12 is then withdrawn through
catheter body 14. At the time of device removal, the blood vessel
will be thrombosed and totally or mostly occluded. Subsequent
fibrosis of the thrombus will make the occlusion substantially
permanent.
A second embodiment 110 of the lumen occlusion system of the
present invention is illustrated in FIGS. 4 and 5. System 110 is
similar to system 2 in that it includes a proximal handle and an
external, dispersive electrode coupled to an RF power supply (see
FIG. 1). The system 110 differs from system 2, however, in that it
includes a plurality of resilient hooks 112-114 for grasping
vaso-occlusive coil 100 and delivering a radiofrequency current
thereto. As shown in FIG. 4, a positioner shaft 116 has a proximal
end (not shown) connected to the proximal handle, a distal end 118
and an axial lumen 119. An inner rod 120 is slidably positioned
within axial lumen 119 and connected to an actuator mechanism (not
shown) on the proximal handle.
Resilient hooks 112-114 are connected to the distal end of rod 118
and biased outward into a spaced apart configuration (not shown).
When hooks 112-114 are completely or partially (FIGS. 4 and 5)
withdrawn into shaft 116, the inner wall 122 of shaft 116 urges the
hooks 112-114 towards each other. One or more of the hooks 112-114
is also an active electrode for delivering RF energy to coil 100.
To that end, positioner shaft 116 includes an electrical conductor,
such as a wire (not shown) extending through rod 118 to couple
active electrode 112 with the RF power supply.
Occlusion system 110 can be used for deploying vaso-occlusive coil
100 at a target site TS in a blood vessel BV and for delivering
radiofrequency energy to coil 100 to enhance fibrogenic occlusion
of the target site TS. In use, hooks 112-114 are moved proximally
outward beyond the distal end of positioner shaft 116 so that they
are spaced apart from each other. The coil 100 is then positioned
between hooks 112-114 and the hooks are partially withdrawn into
shaft 116 so that the inner wall (not shown) of shaft 116 urges the
hooks 112-114 together to grasp coil 100 (this partially withdrawn
position is depicted in FIGS. 4 and 5). Positioner shaft 116 and
coil 100 are then advanced through catheter body 4 to the target
site (the distal end 8 of catheter body 4 is positioned at the
target site as described previously). The inner wall 122 of
cathetor body 4 facilitates the interlock between hooks 112-114 and
coil 100 during movement through the catheter body.
Once coil 100 is advanced beyond the distal end 8 of catheter body
4, it will begin to relax into a convoluted configuration for
occlusion of blood vessel BV, as shown in FIG. 4. Positioner shaft
116 is advanced until at least a portion of coil 100 or the entire
coil and the hooks 112-114 extend beyond the distal end 8 of
catheter body 4 (FIG. 5). An RF voltage is then delivered through
active electrode or hooks 112-114 to the coil to generate thermal
damage within blood vessel BV and induce subsequent fibrogenic
occlusion of the blood vessel (as discussed previously). Since coil
100 is held in position by hooks 112-114, it will not migrate from
TS during the occlusion process. Once the target site is damaged,
localized swelling and thrombosis fixes coil 100 in place. Rod 120
is then moved distally to expand hooks 112-114 and release the coil
100. Rod 120 is typically biased proximally to a closed hook
position. The positioner 116 and catheter 4 can then be removed
from the patient's vasculature.
After the occlusion system has been removed from the blood vessel
BV, a secondary RF treatment may become necessary if, for example,
the target site is not sufficiently occluded. In this case, the
occlusion system will be re-inserted as described above to
re-access the occlusion coil 100, to recouple the coil to the RF
electrode and to deliver additional RF energy to the target
site.
FIGS. 6 and 7 illustrate bipolar embodiments of the present
invention. Referring to FIG. 6, a positioner 150 comprises a
flexible shaft 152 extending through catheter body 4 as in the
previous embodiments. Positioner 150 includes one bipolar electrode
in the form of a disc 154 disposed at the distal end of shaft 152.
Disc 154 is electrically coupled to the RF power source by an inner
conductive wire 156 extending through shaft 152. Shaft 152 is
contained within an electrically conductive sheath proximal to its
distal end to form a second electrode 158. Second electrode 158 is
coupled to RF power source 40 by a second inner conductive wire 160
that extends through shaft 152 and is electrically insulated from
wire 156. Note that second electrode 158 is schematically
illustrated in FIG. 6 and may be larger than that shown. Second
electrode 158 will preferably have a larger surface area than disc
154 and coil 100 to minimize tissue damage at the second
electrode.
In use, positioner shaft 152 is advanced beyond the distal end of
catheter body 4 so that active electrode disc 154 contacts the
vaso-occlusive coil 100 deployed at the target site TS within blood
vessel BV, as shown in FIG. 6. Electrode disc 154 may also be used
as a pusher to deploy coil 100 by pushing the coil through catheter
body 4. RF voltage is applied between electrode 158 and electrode
154 so that an RF current is initiated therebetween. Since the coil
is more conductive than tissue, the RF current flows through at
least a portion of coil 100. The surrounding blood and other fluids
provide a path for the RF current from coil 100 and electrode 154
to electrode 158. The RF current will be sufficient to coagulate
blood and to generate thermal damage to the intima of the tissue
wall to enhance the occlusion of target site TS.
Referring to FIG. 7, another embodiment of positioner 170 comprises
a shaft 172 and a pair of jaws 174, 176 extending from a distal end
of shaft 170. Similar to previous embodiments, positioner 170
includes an inner rod 178 slidably disposed within shaft 172 and
coupled to a proximal actuator (not shown) for opening and closing
jaws 174, 176. In this embodiment, first jaw 174 and a distal
portion 180 of second jaw 176 are the first electrodes. The second
electrode 158 is disposed proximal to the first electrodes 174,
176, similar to FIG. 6. The jaws 174, 176 and second electrode 158
are each coupled to an RF power source by inner conducting elements
184, 186, respectively, which can comprise wires, rods or the like.
RF voltage is applied between jaws 174, 176 and second electrode
158 to initiate RF current therebetween (via the coil).
Although the foregoing invention has been described in some detail
by way of illustration and example, for purposes of clarity of
understanding, it will be obvious that certain changes and
modifications may be practiced within the scope of the appended
claims.
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